Catalog Number

148-519

Brand Name

Nautilus

Version/Model Number

148-519

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111953

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

0cfd7f43-f90b-4110-a756-0cf26e534d2f

Public Version Date

November 14, 2019

Public Version Number

1

DI Record Publish Date

November 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-